CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Precision Dose Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-1004-2020 — Precision Dose Inc. Precision Dose Inc. recalls Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL Hello, I own a Precision Dose Inc. recalls Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit that is covered by recall D-1004-2020 from Precision Dose Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
